Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-25 @ 2:52 AM
NCT ID:
NCT04674033
Eligibility Criteria:
Inclusion Criteria:
Mothers:
* Pregnant women prior to 28 weeks gestation
* Report the least NNS consumption of pre-screened participants (0 servings per week - representing the control group) and most NNS consumption of pre-screened participants (≥ 5 servings per week - representing the experimental group).
* 18-40 years of age
* Singleton pregnancy
* Be able/willing to understand the procedures of the study
* Be able to read English at a 5th grade level (materials also available in Spanish, if required)
Infants:
* Infant's mother must be enrolled in the study and provide infant assent to participate
Exclusion Criteria:
Mothers:
* Physician diagnosis of a major medical illness
* Pre-existing diabetes (type 1 or type 2), or GDM in a previous pregnancy
* Physical, mental, or cognitive issues preventing participation
* Medications that may affect body weight, body composition, insulin resistance, or lipid profiles
* Tobacco or drug use (any current use or quitting during pregnancy)
* Alcohol consumption during pregnancy (\>1 drink per week)
Infants:
* Presumed or known congenital birth defects
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04674033
Study Brief:
Protocol Section:
NCT04674033